The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Ivena Vascular Patch.
Device ID | K060396 |
510k Number | K060396 |
Device Name: | IVENA VASCULAR PATCH |
Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
Contact | Joseph P De Paolo |
Correspondent | Joseph P De Paolo ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
Product Code | DXZ |
CFR Regulation Number | 870.3470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-15 |
Decision Date | 2006-05-12 |